All European inspectors ask for a site master file that complies with the "Explanatory Notes on the preparation of a Site Master File" of Part III of the EU GMP Guide als well as with the identical 2011 revision of the PIC/S guidance document PE 008 “Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File”.

If you don’t have an updated site master file – or a site master file at all – you’re out of compliance with dozens of new or changed requirements.

This report will help you perform a comprehensive gap analysis that assures your Site Master File matches your company‘s activities. In addition, readers will review:

Up-to-date explanations and analysis of all the new Site Master File changes

A sample document illustrating what the newly overhauled Appendix 8 (Equipment and Devices for Production and Quality Control) of a Site Master File should look like

A complete sample Site Master File to use as a template

A thorough review of the elements every Site Master File must include

And much more...

Your guide, Cornelia Wawretschek, is author of a chapter in the GMP MANUAL, Good Manufacturing Practices and Implementation, from which The Drug Manufacturer’s Guide to Site Master Files is adapted.

Remember — Without an up-to-date Site Master File, you are not authorized to market pharmaceuticals to European customers. Don’t risk it.

Cornelia Wawretschek has been working as a freelance QA consultant for 15 years. She has many years of experience in the areas of pharmaceutical processes and analysis with a focus on the development of semi-solid and liquid dosage forms, sterile production as well as investigational medicinal products.